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Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

NCT04660552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-06-03

Study results available
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Summary

The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 6, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 8 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG.

Conditions

Interventions

DEVICE

Cognilum TM: Light Treatment Condition

The children will wear the CognilumTM device for up to 15 minutes at a time, twice a week, for a period of 8 weeks.

Sponsors & Collaborators

  • JelikaLite LLC

    lead INDUSTRY

Principal Investigators

  • Yuli Fradkin, MD · RDT Group NJ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2022-12-31
Completion
2023-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04660552 on ClinicalTrials.gov